CVRx, Inc.

CVRx, Inc. (NASDAQ: CVRX) is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular disease. The company's website is www.cvrx.com.

The company's primary product is Barostim, the first FDA-approved medical device that uses neuromodulation to improve symptoms in patients with heart failure with reduced ejection fraction (HFrEF). Barostim is an implantable device consisting of an implantable pulse generator and stimulation lead that delivers electrical pulses to baroreceptors located in the carotid artery wall. This therapy, known as Baroreflex Activation Therapy (BAT), works by counteracting decreased baroreceptor signaling and rebalancing the autonomic nervous system, thereby reducing the neurohormonal excess that drives heart failure progression. The device complements guideline-directed medical therapy and is designed to improve exercise capacity, quality of life, and functional status in eligible patients.

CVRx received FDA Breakthrough Device designation for Barostim in heart failure treatment and obtained premarket approval in August 2019 following successful completion of the BeAT-HF pivotal trial. The company's clinical evidence base includes data from three heart failure studies evaluating 624 patients across the United States, Germany, Italy, France, Canada, and the United Kingdom. Barostim's trial results have been published in more than 65 peer-reviewed publications, including major journals such as the Journal of the American College of Cardiology and the European Journal of Heart Failure.

The company generated revenue of $56.7 million for the year ended December 31, 2025, with a gross margin of 85 percent. CVRx primarily sells Barostim to hospitals through a direct sales organization in the United States and Germany, and through distributors in Austria, Spain, and other European countries. The company's sales and marketing efforts target heart failure specialists, interventional cardiologists, general cardiologists, electrophysiologists, vascular surgeons, and cardiothoracic surgeons at high-volume cardiology centers.

In November 2025, the FDA granted an investigational device exemption for the BENEFIT-HF trial, a prospective, randomized controlled trial designed to evaluate Barostim's impact on all-cause mortality and heart failure decompensation in an expanded patient population. A successful outcome could expand the company's addressable market opportunity significantly.